Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

Chronic Hepatitis C Clinical Trial

Official title:

Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418639
• Other study ID #: RM01-3027
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2007
• Last updated: January 3, 2007
• Start date: February 2005

Study information

• Verified date: January 2007
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effect of treatment with 24 weeks nitazoxanide monotherapy on end of treatment virologic response, sustained virologic response, reduction of quantitative serum HCV RNA, changes in ALT and safety parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA.

• Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.

Exclusion Criteria:

• Patients unable to take oral medications.

• Use of interferon alpha within 90 days or ribavirin within 30 days prior to enrollment.

• Females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.

• Any investigational drug therapy within 30 days prior to enrollment.

• Patients with other causes of liver disease.

• Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus based on enzyme immunoassay.

• Patients with history of alcoholism or with an alcohol consumption of >40 grams per day.

• Patients who are clinically unstable.

• Patients with any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed.

• History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Nitazoxanide

Locations

Country	Name	City	State
Egypt	Department of Tropical Medicine & Infectious Diseases, Alexandria University	Alexandria
Egypt	Cairo Liver & GIT Center	Cairo
Egypt	Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic response
Secondary	Sustained virologic response
Secondary	Quantitative serum HCV RNA
Secondary	Changes in ALT